Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization

Phase 1

• Conditions: Mastitis
• Interventions: Biological: Lactobacillus salivarius PS2; Biological: Excipient (milk powder)

• Registration Number: NCT01505361
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Last Update Submitted: 2012-01-11
• Last Update Posted: 2012-01-12
• Primary Completion: 2012-03
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Normal pregnancy
• Healthy women
• Lactational mastitis in, at least, a previous lactation period
• No symptomatic vaginal infections

Exclusion Criteria

• Any kind of health problems related to pregnancy
• Symptomatic vaginal infections
• Allergy to cow's milk protein
• Intolerance to lactose
• Antibiotic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Lactobacillus salivarius PS2	Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)
Placebo	Excipient (milk powder)	Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)

Primary Outcome Measures

Name	Time	Method
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts	Weekly during the first 6 months after birth

Secondary Outcome Measures

Name	Time	Method
Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab	At weeks 30, 35, 40 of pregnancy

Trial Locations

Locations (1)

Public Primary Health Care Centers network; 🇪🇸 Madrid, Spain